Authorized USP Pending Standards

Version 1

Lamivudine Tablets / 1
Chromatographic purity

BRIEFING

Buffer solution, Mobile phase, Diluent and

Lamivudine Tablets. This monograph was posted on the USP
Pending Standards Web page for review and public comment for
more than 90 days. No comments were received. The Monograph
DevelopmentAntivirals and Antimicrobials Expert Committee
approved the monograph as an Authorized USP Pending Standard.
The liquid chromatographic procedures in the test for Chromatographic purity and in the Assay are based on analysis performed with
the Hypersil BDS C18 brand of L1 column. The typical retention
time for the lamivudine peak is between 9.0 and 12.5 minutes.
RTSC49300

Standard solutionUse the Standard preparation, prepared as directed in the Assay.

Test solutionUse the Assay preparation, prepared as
directed in the Assay.
ProcedureUsing the chromatogram for the Assay prep-

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(MD-AA: H. Ramanathan; B. Davani)

Chromatographic systemPrepare as directed in the Assay.

aration obtained in the Assay, calculate the percentage of

each impurity in the portion of Tablets taken by the formula:
100 (ri / rS)

Add the following:

"Lamivudine

Tablets

in which ri is the peak response for each impurity obtained

v. 1 Authorized September 1, 2008

from the Test solution; and rS is the sum of the responses for

all the peaks. Not more than 0.1% of any single unknown

Lamivudine Tablets contain not less than 90.0

impurity is found; not more than 0.2% of any individual

known impurity is found, and not more than 0.6% of total

percent and not more than 110.0 percent of the

impurities is found. [NOTEDisregard peaks at relative

labeled amount of lamivudine (C 8H11N3O3S),

retention times of about 0.4 and 0.9 and salicylic acid at

calculated on the dried basis.

about 2.3. These process impurities are monitored in the drug

Packaging and storagePreserve in well-closed containers,

protected from light. Store at room temperature.

USP Reference standards h11iUSP Lamivudine RS.

substance.]
Assay

BufferTransfer about 1.9 g of ammonium acetate to a

1000-mL volumetric ask, dissolve in about 900 mL of water,

Identication
A:

adjust with acetic acid to a pH of 3.8+0.2, dilute with water

Ultraviolet Absorption h197Ui.

Solution:

0.01 mg per mL.

Medium:

phosphoric acid in water (1 : 1000).

Absorption:
B:

to volume, and mix.

Mobile phasePrepare a ltered (0.45-mm lter or ner)

Exhibits maximum at about 277 nm.

The retention time of the major peak in the

chromatogram of the Assay preparation corresponds to that

of the major peak in the chromatogram of the Standard
preparation, obtained as directed in the Assay.

and degassed mixture (95 : 5) of Buffer and methanol. Make

adjustments as necessary (see System Suitability under
Chromatography h621i).
DiluentUse Mobile phase.
Standard preparationDissolve an accurately weighed
quantity of USP Lamivudine RS in Diluent, to obtain a

Dissolution h711i[To come.]

solution having a known concentration of about 0.25 mg per

Loss on drying h731iDry at 1058 for 2 hours; it loses not

mL of lamivudine. Pass a portion of this solution through a

more than 6.0% of its weight.

nylon lter having a 0.45-mm or ner porosity.

Uniformity of dosage units h905i:

meets the requirements.

This monograph has been developed under USPs Pending Standards Guideline, and is not a USPNF monograph.
http://www.usp.org
# 2008 The United States Pharmacopeial Convention All Rights Reserved.

Authorized USP Pending Standards

Version 1

2 / Lamivudine Tablets
Assay preparationPlace 10 Tablets in a 250-mL volu-

ProcedureSeparately inject equal volumes (about 10 mL)

metric ask. Add about 100 mL of Diluent, and sonicate for

of the Standard preparation and the Assay preparation into

15 minutes. Dilute with Diluent to volume. Mix well. Allow

the chromatograph, record the chromatograms for about 2.5

the solution to settle down for about 10 minutes. Dilute 4 mL

times the retention time of lamivudine, and measure the peak

of this solution to 100 mL with Diluent. Pass a portion of this

responses for lamivudine. Calculate the percentage of

solution through a nylon lter having a 0.45-mm or ner

C8H11N3O3S in the portion of Tablets taken by the formula:

porosity.
100(CS / CU)(rU / rS)

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Chromatographic system (see Chromatography h621i)

The liquid chromatograph is equipped with a 277-nm detector

and a 4.6-mm 6 25-cm column that contains 5-mm packing

in which CS is concentration of lamivudine, in mg per mL, in

L1. The ow rate is about 1.0 mL per minute. The column

the Standard preparation; CU is the nominal concentration of

temperature is maintained at 358. Chromatograph the

lamivudine, in mg per mL, in the Assay preparation; and rU

Standard preparation, and record the peak areas as directed

and rS are the peak responses of lamivudine obtained from the

for Procedure: the relative standard deviation for ve

Assay preparation and the Standard preparation, respec-

replicate injections is not more than 2.0%.

tively.3(1-Sep-2008)

This monograph has been developed under USPs Pending Standards Guideline, and is not a USPNF monograph.
http://www.usp.org
# 2008 The United States Pharmacopeial Convention All Rights Reserved.